Remimazolam Sedation for Nerve Blocks

Procedural Pain Clinical Trial

— REMI-SEN  

Official title:

Remimazolam Safety and Efficacy for Nerve Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415202
• Other study ID #: IRB_00149157
• Status: Completed
• Start date: June 6, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study recording sedation and safety of patients undergoing remimazolam sedation for peripheral nerve blocks.

Objectives:

To explore the safety and efficacy of remimazolam for neuraxial procedures and peripheral nerve pre-blocks and re-blocks.

Patients undergoing epidurals, fascial plane blocks, and peripheral nerve blocks will receive remimazolam for sedation.

Specific outcomes to assess include: depth of sedation, length of sedation, presence of apnea, presence of nausea/vomiting/other side effects, if the sedation was sufficient for the procedure.

Assessment methods:

MOAAS - Modified Observer's Assessment of Alertness and Sedation score Subjective patient report Vital signs Time for recovery Side effects

Hypothesis:

Remimazolam provides short-acting, adequate and safe sedation for peripheral nerve blocks in the ambulatory setting.

Description:

Nerve blocks are short, mildly stimulating procedures that result in no increase in pain post-procedurally. They are often performed at our institution with sedation, typically midazolam with or without fentanyl.

Remimazolam is an intravenous sedative agent FDA approved for procedural sedation.

Remimazolam is an intravenous sedative agent FDA approved for procedural sedation. It has been shown to be safe and effective in outpatient colonoscopy and has demonstrated a faster recovery to neuropsychiatric function compared to midazolam.[i] It also has demonstrated decreased rates of hypotension and faster recovery time when compared to midazolam.i For high risk colonoscopies, similar rates of bradycardia and blood pressure changes have been found; and remimazolam was shown to be safe and short acting.[ii] For bronchoscopies, remimazolam continues to demonstrate faster return to neuropsychiatric function when compared to midazolam, as well as a safety profile equivalent to midazolam.[iii]

With a safety profile equivalent to midazolam but a much shorter duration of effect, it is a natural choice for a short, mildly stimulating procedures such as nerve blocks.

Patients will be identified by providers and study personnel according to inclusion and exclusion criteria by reviewing electronic charts of patients who will be receiving nerve blocks. Once identified as a possible pre-op block or re-block, then the patients will be approached and asked if they wish to participate in the study. Patient will be screened by chart review and questioning for allergies to remimazolam or dextran 40 and will be excluded if allergy is present.

After patients are identified by providers or study personnel as meeting the inclusion/exclusion criteria on the day of surgery, they will be approached and asked if they wish to participate in the study. If they choose to participate, then a provider or study personnel will perform the informed consent process.

BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. For this study, remimazolam will be used according to its FDA approval, for procedural sedation in adults undergoing procedures lasting 30 minutes or less: peripheral nerve blocks, catheters, plane blocks, or epidural procedures. Route: Intravenous.

The nerve block will then be performed under standard conditions with standard monitors. Remimazolam will be used for sedation following the guidelines on the label.

Dosing will be as follows:

Induction of Procedural Sedation For adult patients: Administer 5 mg intravenously over a 1-minute time period. For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient.

Maintenance of Procedural Sedation (as needed) For adult patients: Administer 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose.

For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds.

At least 2 minutes must elapse prior to administration of any supplemental dose.

MOASS scores will be assessed at baseline and frequently until 3 consecutive 5's are observed. The patient will be monitored until they have scored three consecutive 5's on the MOASS scale and their vital signs are stable. Any additional required sedative medications will be recorded, as will vital signs and side effects.

Supplemental oxygen may be administered as needed.

Patients are not eligible to participate in the study more than once.

[i] Rex, D. K., Bhandari, R., Desta, T., DeMicco, M. P., Schaeffer, C., Etzkorn, K., et al. (2018). A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared with Placebo and Midazolam in Patients Undergoing Colonoscopy. Gastrointest. Endosc. 88 (3), 427-437.e6. doi:10.1016/j.gie.2018.04.2351

[ii] Rex, D. K., Bhandari, R., Lorch, D. G., Meyers, M., Schippers, F., and Bernstein, D. (2021). Safety and Efficacy of Remimazolam in High Risk Colonoscopy: A Randomized Trial. Dig. Liver Dis. 53 (1), 94-101. doi:10.1016/j.dld.2020.10.039

[iii] Pastis, N. J., Yarmus, L. B., Schippers, F., Ostroff, R., Chen, A., Akulian, J., et al. (2019). Safety and Efficacy of Remimazolam Compared with Placebo and Midazolam for Moderate Sedation during Bronchoscopy. Chest 155 (1), 137-146. doi:10.1016/j.chest.2018.09.015

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Will be receiving a pre-operative nerve block (single shot nerve block, nerve block catheter, plane block, epidural, etc.) or a re-block (a nerve block performed for pain control at least one day after surgery) from a qualified APS team member.

Exclusion Criteria:

1. Age less than 18 years.

2. Clinical instability or other condition preventing nerve block or sedation.

3. Pregnancy.

4. Inability to communicate quickly and efficiently their level of perceived sedation.

5. Allergy to remimazolam or dextran 40.

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Anxiety
• Procedural Pain

Intervention

Drug:
• Remimazolam 20 MG [Byfavo]
Remimazolam will be administered for sedation and efficacy and safety will be recorded

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (3)

Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4. — View Citation

Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30. — View Citation

Rex DK, Bhandari R, Lorch DG, Meyers M, Schippers F, Bernstein D. Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial. Dig Liver Dis. 2021 Jan;53(1):94-101. doi: 10.1016/j.dld.2020.10.039. Epub 2020 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change during procedure in Modified Observer's Assessment of Alertness/Sedation Scale score	Sedation efficacy will be measured by serial scores on the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS: 5 is awake and alert, 0 is deep sedation). It will be measured each minute until 3 consecutive 5's are achieved.	Each minute during procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Nerve block completion or abortion	Will record if the nerve block was completed or aborted	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Additional sedative requirement	Will record if additional sedative medications were required in order to achieve acceptable level of sedation in order to complete the procedure.	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Oxygen Requirement	Oxygen requirement will be recorded. Will include liters per minute of oxygen administered as well as method of delivery.	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Change in oxygen saturation as measured by pulse oximetry	Continuous pulse oximetry will be measured throughout the procedure and recorded every 2.5 minutes from prior to administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Change in systolic blood pressure	Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Change in diastolic blood pressure	Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Change in mean arterial blood pressure	Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Change in Heart Rate	Heart rate will be measured continuously and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Required airway intervention	Any required airway intervention will be recorded including (but not limited to): intubation, mask ventilation, oral airway, positive pressure ventilation, reversal agent administration, procedure cancellation	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)
Secondary	Required hemodynamic intervention	Any required hemodynamic intervention will be recorded including (but not limited to): reversal agent administration, vasoactive substance administration, procedure cancellation	From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)